One method of modifying cellular tissues in situ requires heating the tissues, and causing them to shrink and tighten. It is often less traumatic than surgical procedures and may be the only alternative method, wherein other procedures may be unsafe, complicate, or ineffective. Ablative treatment devices have an advantage because of using a destructive energy that is rapidly dissipated and reduced to a non-destructive level by conduction and convection, to forces of circulating fluids and other natural processes.
The destructive energy used includes microwave energy, radiofrequency energy, ultrasonic energy, cryogenic means, laser energy, and tissue destructive substances. They have been used to destroy malignant, benign, and other types of cells and tissues from a wide variety of anatomic sites and organs. Tissues treated include isolated carcinoma masses and, more specifically, organs such as the prostate, glandular and stromal nodules characteristic of benign prostate hyperplasia. These devices typically include a catheter or cannula which is used to carry a radiofrequency electrode or microwave energy antenna, through a duct, to the area of treatment, and applying energy diffusely through the duct wall into the surrounding tissues in the targeted directions.
Of particular interest to the present invention are ultrasonic energy therapeutic protocols, which have been proven to be highly effective. The traditional radiofrequency ablation provides therapeutic energy by heat conduction while the ultrasonic ablation can provide a deeper energy penetration by remote energy transmissions. By heating the tissues deeply, and causing them to shrink and tighten, the loosen tissue can be tightened and restored to its healthy state. Ultrasonic energy, when coupled with a temperature control mechanism, can be supplied to the device-to-tissue contact site and deep into the tissue zone precisely to obtain the desired tissue treatment. Ultrasonic energy is conveyed to the tissue by heat conduction and remote penetration.
To be more efficient in ultrasonic energy ablation, an ultrasonic transducer means with a vibration capability can be used to simultaneously deliver the massage therapy to the target tissues. The electric toothbrush with vibration has been disclosed in the following patents: Suyama in U.S. Pat. No. 4,944,296, Ng in U.S. Pat. No. 5,283,921, Hwang in U.S. Pat. No. 5,381,576, Okada in U.S. Pat No. 5,421,726, Mei in U.S. Pat. No. 5,617,603, and Hahn in U.S. Pat. No. 5,651,157. All the above patents disclose the advantage of an electric toothbrush with vibration. However, they do not teach using an ablation means with vibration capability to treat the tissues for therapeutic purpose.
On the other hand, Imran in U.S. Pat. No. 5,281,218 entitled "Catheter having needle electrode for radiofrequency ablation" teaches a method using a needle electrode that is attached onto a catheter for radiofrequency ablation. Though a needle-like electrode is beneficial to ablate a tissues point, it is not disclosed that the particular needle electrode could possibly combine pressure therapy and ultrasonic energy for proper contact with the target tissues. The "pressure therapy" is defined in this invention as applying appropriate pressure onto the tissues by a medical device.
Hemorrhoid is a varicose dilatation of a vein of the superior or inferior hemorrhoidal plexus, resulting from a persistent increase in venous pressure. The external hemorrhoid is a varicose dilatation of a vein of the inferior hemorrhoidal plexus, situated distal to the pectinate line and covered with modified anal skin. The internal hemorrhoid is a varicose dilatation of a vein of the superior hemorrhoidal plexus, originating above the pectinate line, and covered by mucous membrane. A more serious case of hemorrhoid, prolapsed hemorrhoid, is an internal hemorrhoid that has descended below the pectinate line and protruded outside the anal sphincter. One of the worst cases, strangulated hemorrhoid, is an internal hemorrhoid which has been prolapsed sufficiently and for long enough time for its blood supply to become occluded by the constricting action of the anal sphincters.
Taylor in U.S. Pat. No. 5,578,047 teaches a hemorrhoid-removing device. Tuffel in U.S. Pat. No. 4,938,221 teaches a hemorrhoid inflammation-reducing device. Bidoia in U.S. Pat. No. 5,203,863 teaches an instrument for the ligation of hemorrhoids. None of them discloses a medical device by using a suitable energy to treat a dilated vein to shrink it. On the other hand, an alternative for hemorrhoid treatment is by surgically removing the dilated vein by a laser or other means. For a dilated vein, RF energy or other suitable energy can be applied for treating the tissues of the vascular walls, and causing them to shrink and tighten.
Marcus et al. in U.S. Pat. No. 5,295,484 and Castellano et al. in U.S. Pat. No. 5,606,974 teach a catheter system having ultrasonic device for intracardiac ablation of arrhythmias. However, neither discloses a medical device having ultrasonic energy and pressure/vibrational therapy to treat the hemorrhoid tissues effectively.
Therefore, there is a need for an improved medical device and methods using the ultrasonic energy to treat a dilated vein or tissue, such as hemorrhoids or tumors, while simultaneously applying pressure and/or vibrational massage therapy.